Novo Nordisk applies to FDA, E.U. for diabetes drug approval
DENMARK Novo Nordisk has asked U.S. and European regulators to approve its new diabetes treatment, liraglutide, according to Bloomberg.
Liraglutide is a synthetic version of glucagon-like peptide-1, a hormone that stimulates the pancreas to produce insulin. Diabetics don’t naturally make enough insulin to absorb sugar, which collects in the blood rather than being absorbed by muscle and fat cells. This accumulation of glucose can lead to kidney failure, blindness and heart disease.
Unlike the natural hormone, which has a life of little more two minutes, liraglutide persists in the blood for 24 hours. Tests in rats indicate it helps pancreatic cells to multiply, suggesting its use may slow or even reverse organ damage caused by diabetes.
“This could nearly double the $2 billion-plus of diabetes sales we currently forecast in 2012,” Jack Scannell, an analyst at Bernstein Research, said in a May 7 investor note. Novo Nordisk may report liraglutide sales of $2 billion in 2012, and the figure will rise if clinical trials show the drug also cuts obesity and prevents diabetes, he said.
FDA approves Teva’s generic Sarafem Pulvules
JERUSALEM The Food and Drug Administration has granted final to Teva Pharmaceuticals to market a drug for treating premenstrual dysphoric disorder.
The drug, fluoxetine, is a generic version of Eli Lilly’s drug Sarafem Pulvules. The FDA granted approval for Teva’s application for 10 mg and 20 mg capsules of the drug Wednesday. The FDA granted a first-to-file 180-day marketing exclusivity to Teva. The drug will ship immediately.
Teva, headquartered in Israel, is a manufacturer of generic drugs and one of the 20 largest pharmaceutical companies in the world. Teva North America operates in California, Missouri, Florida, New York, New Jersey and Pennsylvania.
FDA issues approvable letter for Wyeth osteoporosis drug
WASHINGTON Wyeth Pharmaceuticals received an approvable letter from the Food and Drug Administration for a drug to treat postmenopausal osteoporosis, the company announced Friday.
The FDA requested further analysis concerning stroke and venous thrombosis for the drug, known as bazedoxifene. The FDA made similar requests when Wyeth Pharmaceuticals filed a new drug application in December 2007. The company expects to respond to the new letter by the end of this year.
Wyeth Pharmaceuticals is a division of Wyeth, a global company specializing in pharmaceuticals, consumer healthcare products and animal healthcare products.